Ipsen debuts Decapeptyl in France, Recordati gains EU clearance for silodosin

French specialty drugmaker Ipsen and Swiss biopharmaceutical group Debiopharm have announced the launch by Ipsen in France of Decapeptyl (triptorelin embonate1) LP 22.5mg six-month sustained-release formulation for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. Other launches are planned shortly, notably in Germany and Portugal.

The marketing authorization (MA) to this formulation of Decapeptyl was granted on November 10, 2009, by the French regulatory authority (Agence Française de Securite Sanitaire des Produits de Sante, AFSSAPS) for the treatment of locally advanced and metastatic hormone-dependent prostate cancer.

France was the first country to approve Decapeptyl LP 22.5mg in the context of a Decentralized Procedure in Europe. The reimbursement rate by Social Security and price setting decision were published in the Journal Officiel of February 3, ie, less than three months after MA was granted, the French drugmaker noted.